This invention relates to a gel composition for use as a delivery system for nutrients, medicaments, vitamins, minerals, herbal and nutritional supplements.
Various systems are known for use as carriers for delivering drugs, medicaments and nutritional supplements. For example, in U.S. Pat. No. 4,950,689 a pectin delivery system is described. This system seeks to deliver fiber with good taste by utilizing a pectin gel delivery system to form a confectionery unit combined with an edible insoluble solid to strengthen the chewable pectin gel network. The delivery system can be used to deliver a drug such as a laxative.
U.S. Pat. No. 4,857,331 describes a similar system, which is sugarless, including an algin gel component with a pectin component. U.S. Pat. No. 5,747,058 describes a high viscosity liquid composition for the delivery of substances, using a non-polymeric, non-water soluble high viscosity liquid carrier material that does not crystallize neat under ambient or physiological conditions. Sucrose acetate isobutyrate is described as such a substance.
In U.S. Pat. No. 4,576,645 a whipped gel composition is described that is useful to form a vehicle for delivering a spoonable soft gel composition to deliver substances to children.
While various substance delivery systems have been suggested, the search continues for delivery compositions that are low in cost, good tasting and render not only medicaments, but other nutritional substances palatable to children and easy to administer to adults. For example, various herbs and natural substances have gained popularity because they have beneficial properties, but these are dependant on bioavaliabilty to achieve the desired results. Many of these substances are unpalatable to children, who resist taking them. All too often, the benefits are not obtained because the normal digestive process degrades bioavailability and typical carriers, if any are used, do not promote bioavailability. In such a case, cost is an important factor. A sophisticated polymeric drug delivery system would likely not be practical for the delivery of, for example a vitamin C or E supplement to children. Consequently, a delivery system which increases bioavailability of the delivered substance, but at low cost, would be a particular benefit over the carriers used in the prior art.
It is an object of the present invention to provide a delivery composition that promotes bioavailability of the delivered component.
It is a further object to provide a delivery system that has a range of consistency to provide formulations from being spoonable to a rigid gel.
It is yet another object to provide a delivery system which is of low cost to allow use with various herbs, vitamin and nutritional supplements.
It is another object to provide a good tasting delivery system which masks the taste of the delivered substances.
These and other objects of the present invention are achieved by a delivery composition comprising a gel base, water and a bioavailability enhancing composition. Agar is a preferred gelling agent, most preferably used with gelatin to form a base. Agar is a phycocolloid derived from red algae, that is strongly hydrophilic. Agar is preferred to pectin because its smaller molecular structure helps in absorption of the delivered component. The gelatin/agar base provides a flexible base that can cover a full range of consistency, from spoonable suspension to a rigid gel. The base provides a stable environment for both water and lipid soluble substances. The bioavailability enhancing substance is preferably a surfactant such as a mixture of lecithin and Vitamin E which promotes absorption of the carried substance. Other ingredients, such as flavoring agents, coloring agents or thickeners, among others, can be incorporated in the present invention.
The present invention is a gel delivery system which uses a combination of mechanisms to enhance substance absorption. The mechanisms involve micellar solubilization, solid dispersion, and in situ emulsification. These improve the surfactant qualities of the gel preparation. Preferably, the inventive composition further comprises ingredients that support growth of selective gut micro flora that promote or maintain normal digestive function. The gel preferably has an all natural composition for delivering substances such as vitamins and minerals in a way that bypasses the poor disintegration or dissolution problems associated with solid dosage forms such as tablets or capsules. The gel system represents a convenient dosage form for delivering a wide variety of substances such as vitamins, minerals, herbs, food, supplements, medicaments, nutrients and further enhances their bioavailability. Use of the gel permits smaller dosages of vitamins and other nutrients to be used since greater uptake can be achieved. The gel, being an edible water-soluble and pliable matrix, reduces the difficulty in swallowing commonly encountered among children and the elderly population. Also, the gel is an effective taste-masking carrier for substances that have undesirable taste characteristics, due to its unusually high ratio of excipient to active components. For consumer convenience, the system can be packaged in a unit dose form. The gel may be formulated to include multiple vitamins and mineral preparations with their own enhanced bioavailability. The consistency of the gel can be changed to make it more fluid for beverage use or more solid for gummy type chewables.